Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Phase I/II Trial to Evaluate Safety, Tolerability and Pharmacokinetic Profile of HM61713 (BI 1482694) in NSCLC Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier:
NCT01588145
First received: April 26, 2012
Last updated: June 16, 2016
Last verified: June 2016
  Purpose
The main objective of this study is to evaluate the safety and tolerability of HM61713 (BI 1482694).

Condition Intervention Phase
Non Small Cell Lung Cancer
Drug: HM61713 (BI 1482694)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of HM61713 (BI 1482694) in NSCLC Patients With EGFR Mutation

Resource links provided by NLM:


Further study details as provided by Hanmi Pharmaceutical Company Limited:

Primary Outcome Measures:
  • Safety and tolerability [ Time Frame: Dose limiting Toxicity will be evaluated on Day 24 during Cycle 1 ] [ Designated as safety issue: Yes ]

Enrollment: 300
Study Start Date: March 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HM61713 (BI 1482694) Drug: HM61713 (BI 1482694)
BID or QD, PO X 21 day cycle Number of cycles: until progression or unacceptable toxicity develops
Other Name: Olmutinib

Detailed Description:

Besides the main objective, there are 3 other objectives as follows:

  • To evaluate the anti-cancer effect of HM61713 in NSCLC patients with EGFR mutation
  • To investigate the pharmacokinetic profile of HM61713 and its metabolites after oral administration
  • To investigate biomarkers related to the safety and efficacy of HM61713
  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with histologically or cytologically confirmed diagnosis of advanced NSCLC
  • Patients with EGFR mutation-positive tumor
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
  • Estimated life expectancy of at least 12 weeks
  • Subjects with adequate bone marrow (WBC ≥4,000/mm3, Platelet ≥100,000/mm3, Hemoglobin≥9.0g/dL, ANC≥1,500/mm3), renal (Creatinine≤1.5 mg/dl) and hepatic [aspartate aminotransferase (AST)/ alanine aminotransferase (ALT)/ alkaline phosphatase (ALP)≤3 x ULN, Total bilirubin ≤2.0 mg/dL] function. No significant heart and lung disease.

    ※ For subjects with a liver metastases, AST/ALT/ALP≤ 5 x ULN is allowed; and for subjects with bone marrow metastases, ALP≤ 5 x ULN is allowed

  • Patients with amylase level ≤ 1.5 x ULN
  • Subjects who have provided voluntary consent to participate in the study, and signed the written consent document

<Dose escalation part>

- Malignancy that has progressed after at least two prior chemotherapy regimens, including EGFR-TKI

<Expansion part 1>

  • Patients with disease progression despite anticancer therapy with EGFR-TKI (e.g., erlotinib, gefitinib, neratinib, afatinib, dacomitinib)
  • Patients who have provided voluntary consent for collection of tumor tissue taken and archived after the last anticancer therapy or collection of new tissue specimen and signed the written consent document

<Expansion part 2> & <Phase 2>

  • Patients with disease progression despite anticancer therapy with EGFR TKI (e.g., erlotinib, gefitinib, neratinib, afatinib, dacomitinib) (Except treatment with EGFR mutation selective inhibitor, the same class of drug as investigational drug in this study)
  • T790M mutation-positive confirmed in tissue collected after PD is confirmed during or after the last anticancer therapy
  • At least one measurable target lesion allowing repeated measurement according to RECIST ver1.1 as of screening

<Phase 1 Expansion part 3>

  • Patients with disease progression despite anticancer therapy with EGFR TKI (e.g., erlotinib, gefitinib, neratinib, afatinib, dacomitinib) (Except treatment with EGFR mutation selective inhibitor, the same class of drug as investigational drug in this study)
  • T790M mutation-negative confirmed in tissue collected after progressive disease (PD) is confirmed during or after the last anticancer therapy
  • At least one measurable target lesion allowing repeated measurement according to RECIST ver1.1 as of screening

Exclusion Criteria:

  • Hematologic malignancies
  • Symptomatic or uncontrolled central nervous system metastases
  • Interstitial lung disease, including pulmonary fibrosis
  • LVEF < 40% or NYHA Class III or IV heart failure
  • History of pancreatitis
  • History or current evidence, of any psychiatric or congenital disorder, including dementia or epilepsy
  • Compromised organ function, infection or allergy
  • Pregnant or breast-feeding women, or women of child-bearing potential who do not use an appropriate method of contraception (male patients should also use an appropriate method of contraception during the study period)
  • Patients who had received other investigational product within 30 days prior to screening
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01588145

Locations
Korea, Republic of
Seoul, Korea, Republic of
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
Boehringer Ingelheim
Investigators
Principal Investigator: Dong-Wan Kim, MD PhD Seoul National University Hospital
  More Information

Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT01588145     History of Changes
Other Study ID Numbers: HM-EMSI-101 
Study First Received: April 26, 2012
Last Updated: June 16, 2016
Health Authority: Korea: Ministry of Food and Drug Safety

Keywords provided by Hanmi Pharmaceutical Company Limited:
NSCLC
HM61713
BI 1482694
EGFR-TKI
Phase II
olmutinib

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 23, 2016